In February 2024 Dignitana announced that DigniCap Delta received market approval in Japan from the Ministry of Health, Labor and Welfare (MHLW) with Konica Minolta as market authorization holder (MAH) to expand into the Japanese market.

"We are honored to partner with Konica Minolta. This agreement expands the scope of our work together and solidifies the commitment that we share jointly to bring DigniCap Delta's next generation scalp cooling technology to patients in Japan. Konica Minolta's reputation for innovation and quality is well-recognized, and we place great value in their market access and expertise," said Fredrik Jonsson, Dignitana CEO.

"With this agreement we are building on the solid foundation of our shared history with Dignitana. There is strong interest in scalp cooling in Japan, and we are well-positioned to provide the advanced technology in DigniCap Delta to cancer centers across the region," said Toshikazu Imai, General Manager Business development division, Konica Minolta.

Over one million new incidences of cancer are diagnosed annually in Japan. Breast cancer is the most common type of cancer for women in Japan, with over 94 thousand women diagnosed with breast cancer in 2022 (ganjoho.jp) (https://ganjoho.jp/public/qa_links/report/statistics/pdf/cancer_statistics_2023.pdf).

The FDA-cleared DigniCap Delta device uses industry-leading thermoelectric cooling to minimize hair loss that is a side effect of chemotherapy prescribed to treat solid tumors such as those from breast cancer, ovarian cancer and prostate cancer. Recognized internationally as a standard of care and quality of life advancement for cancer patients, scalp cooling is a treatment recommendation in the clinical practice guidelines published by National Comprehensive Cancer Network (https://nccn.org/)® (NCCN), European Society for Medical Oncology (https://www.annalsofoncology.org/article/S0923-7534(20)43157-6/fulltext) (ESMO), and Cancer Australia (https://www.guidancebreastcancer.gov.au/sites/default/files/guidelines/GEBC_Recommendations%20and%20practice%20points_Pdf_Sept%202020.pdf). It is available in cancer centers around the globe.